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date learned from the event

Japanese translation: 有害反応/副作用を知った日から

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:date learned from the event
Japanese translation:有害反応/副作用を知った日から
Entered by: Yasutomo Kanazawa

15:05 Apr 29, 2017
    The asker opted for community grading. The question was closed on 2017-05-02 16:54:13 based on peer agreement (or, if there were too few peer comments, asker preference.)


English to Japanese translations [PRO]
Medical - Medical (general) / clinical trial
English term or phrase: date learned from the event
臨床試験での用語です。
まだnotifiedされていない段階のdate learnedなので、経験した日、と訳したらいいのか迷っています。
どのように訳しますか？

（フレーズが使われている文章）
The applicable Regulatory Authorities and all participating Investigators shall be notified by a written expedited safety report of any suspected adverse reaction that is both serious and unexpected (eg, SUSAR), no later than 15 calendar days from the “date learned” of the event.
arichanbou
Japan
Local time: 22:02
有害反応/副作用を知った日から
Explanation:
adverse reactionとは有害反応/副作用のことを指しますので、それらの事象を知った15日以内に書面での報告書によって通知されなくてはなりません、という意味です。

http://ejje.weblio.jp/content/adverse reaction
Selected response from:

Yasutomo Kanazawa
Japan
Local time: 22:02
Grading comment
ありがとうございます。やはり、「知った日」でいいんですね。深く考えてしまいました。
2 KudoZ points were awarded for this answer



Summary of answers provided
3 +2有害反応/副作用を知った日から
Yasutomo Kanazawa
Summary of reference entries provided
FYR
cinefil

  

Answers


30 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
有害反応/副作用を知った日から


Explanation:
adverse reactionとは有害反応/副作用のことを指しますので、それらの事象を知った15日以内に書面での報告書によって通知されなくてはなりません、という意味です。

http://ejje.weblio.jp/content/adverse reaction

Yasutomo Kanazawa
Japan
Local time: 22:02
Native speaker of: Native in JapaneseJapanese
PRO pts in category: 89
Grading comment
ありがとうございます。やはり、「知った日」でいいんですね。深く考えてしまいました。

Peer comments on this answer (and responses from the answerer)
agree  David Gibney
15 mins
  -> Thank you!
agree  Yoshiro Shibasaki, PhD
3 days 1 hr
  -> ありがとうございます。
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Reference comments


20 mins
Reference: FYR

Reference information:
http://www.csp.or.jp/cspor/upload_files/arch_12.pdf
http://www.jpma.or.jp/medicine/shinyaku/tiken/allotment/chec...

--------------------------------------------------
Note added at 27分 (2017-04-29 15:32:40 GMT)
--------------------------------------------------

https://www.pmda.go.jp/files/000156127.pdf

cinefil
Japan
Works in field
Native speaker of: Native in JapaneseJapanese
PRO pts in category: 324
Note to reference poster
Asker: やはり、上記の方と同じく「知った日」でいいんですね。ありがとうございます。

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